The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Gynecare Morcellex Tissue Morcellator, Models Mx0100 And Mx0100r.
| Device ID | K061050 |
| 510k Number | K061050 |
| Device Name: | GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville, NJ 08876 |
| Contact | Bryan Lisa |
| Correspondent | Bryan Lisa ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville, NJ 08876 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-17 |
| Decision Date | 2006-07-14 |
| Summary: | summary |